A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-up

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Background: Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them.

Objective: To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases.

Eligibility: People aged 3 to 100 years with allergic or sinus diseases.

Design: Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples: * Blood will be collected. * Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose. * Skin cells will be collected by rubbing with a cotton swab. * A urine sample will be collected. * Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test). * Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs. * If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study. * Participants will complete online questionnaires regarding their symptoms, health, and life. Participants may return for more visits for up to 3 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Aged 3 to 100 years.

• a) Suspected or confirmed allergic, atopic, respiratory, or nasal/sinus disorder or have suspected or confirmed history of an immune dysregulatory disorder, OR

• b) Have a clinical history of an immediate hypersensitivity reaction to aeroallergens, food, insect stings, or medications.

• Able to provide informed consent.

• Have or are willing to obtain a non-NIH primary physician who will manage all health conditions and be responsive for emergency medical treatment, if required.

• Willing to allow storage of blood, skin swabs, nasal fluid/brushings, bodily fluids, and other clinically appropriate tissue specimens or data generated during participation for future use in medical research.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Hye Jeong C Bolan, R.N.
NIAIDMADREP@NIH.GOV
(301) 594-1233
Backup
Paneez Khoury, M.D.
paneez.khoury@nih.gov
(301) 402-3673
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2045-11-01
Participants
Target number of participants: 10000
Treatments
Conditions that may be initially evaluated or managed by A&I but not categorized in 1 or 2 above
Conditions that may be initially evaluated or managed by an allergist-immunologist or rhinologist but not categorized in (1) or (2) above (eg, hypereosinophilia, mast cell disorders, pruritus, chronic cough, smell disorders)
Individuals with a suspected allergic or atopic disease
Individuals with a suspected allergic or atopic disease, but without demonstrated allergen sensitization (eg, contact hypersensitivity, chronic spontaneous urticaria, drug allergy)
Individuals with an allergic, atopic, or sinus disease
Individuals with an allergic, atopic, or sinus disease (eg, atopic dermatitis, eosinophilic esophagitis (EoE), asthma, chronic rhinosinusitis with polyposis) with documented allergen sensitization in the skin or blood
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov